November 28, 2022

The FDA’s Definition of “Healthy” is Changing, and What that Means for Your Labels

Editor’s note: This blog post was originally published on October 19, 2022. We have updated the post to reflect the most recent changes as of November 28, 2022.

Nothing says fall like changing leaves, cooler weather, and new proposed rulings from the Food and Drug Administration (FDA)… Well, at least for those of us working in food manufacturing and labeling.

This time around, the FDA is re-evaluating the definition of “healthy” and how food manufacturers should properly label their goods to reflect federal dietary guidance. The proposed rule will have a 140-day public comment period*. If the ruling is finalized, food manufacturers must meet specific criteria if they want to use the term “healthy” on their nutrient content claims or packaging. Let’s explore the ruling in more detail.

What is the FDA definition of “healthy” for food labeling?

According to the FDA, the new proposed definition of “healthy” will align “with current nutrition science, federal dietary guidance, especially the Dietary Guidelines for Americans, 2020-2025, and the updated Nutrition Facts label.” Going forward, food manufacturers should only label food as “healthy” if it offers nutrient-dense ingredients that can help consumers build a consistent diet that meets current dietary recommendations. More specifically, the “healthy” food should:

Contain a certain amount of ingredients from at least one food group or subgroup (e.g., fruit, vegetables, grains, dairy, and protein foods), as described in the 2020-2025 Dietary Guidelines for Americans.
Have specific limits for added sugars, saturated fat, and sodium based on the percentage of Daily Value for those nutrients.
Meet criteria for food group equivalents and reference amount customarily consumed.

Outside of these requirements, raw whole fruits and vegetables will automatically qualify for the “healthy” claim due to their nutrient profile and – as the FDA puts it – “positive contribution to an overall healthy diet.” However, the new definition also expands to include foods that were previously excluded from the definition of “healthy,” such as nuts and seeds, higher-fat fish (like salmon), water, certain oils, and avocados. The FDA also listed some foods that will no longer qualify under the new definition, such as white bread, highly sweetened yogurt, and highly sweetened cereal.

The use of the term “healthy” is voluntary, but these new guidelines would place stricter limits on its use if the ruling is finalized. The initial definition of “healthy” for labeling was created in 1994, but dietary guidelines have changed significantly since then. In 2016, the FDA notified state agencies that it would “exercise enforcement discretion” for products labeled “healthy” until the word could be re-defined, and it has since collected public comments and information on the use of the term. As with many government decisions, the new proposed definition of “healthy” has been years in the making.

What else is included in the proposed rule for “healthy”?

While the FDA is looking to redefine “healthy,” it has simultaneously been looking for a better way to communicate to consumers through food labeling and symbols. Over the past couple years, the FDA has been seeking comments on a “healthy symbol” that can help consumers quickly identify nutrient-rich foods when shopping. As the FDA explains: “Symbols may be particularly helpful for those with lower nutrition knowledge to identify foods that can be the foundation of a healthy eating pattern.”

The FDA first proposed a healthy symbol in May 2021 and issued a second notice in March 2022. While the FDA has yet to finalize the symbol, the current proposal to redefine “healthy” could spur efforts to create a “healthy symbol,” as well. But, as with all government proposals, the public will be given a window to submit comments before a ruling is finalized.

When will the “healthy” definition change?

The FDA is seeking public comments on the proposed definition of “healthy” until February 16, 2023*. Comments can be submitted online or via mail through the Federal Register. Once the Final Rule is released, there will be a 60-day period before it is enforced, followed by an expectation for manufacturers to be compliant within 3 years. As of this posting, the FDA has not announced a release date for the Final Rule.

To help food manufacturers understand the new ruling, the FDA held a webinar on Friday, October 21, 2022. The recording is now available on the FDA website.

*Note: The FDA has extended the comment period for the Healthy Claim, adding an additional 50 days, with the comment period ending February 16, 2023. Previously, when we first published the blog, the comment period was scheduled to end December 28, 2022.

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